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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K122301
Device Name GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
Applicant
Vascular Solutions Zerusa , Ltd.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact JENNIFER RUETHER
Correspondent
Vascular Solutions Zerusa , Ltd.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact JENNIFER RUETHER
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/01/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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